Introduction
Manager & Principal Consultant
Alexandra A. Dilis, J.D., RQAP-GCP, Manager and Principal Consultant is an accomplished quality assurance and regulatory compliance professional with over 13 years of experience in pharmaceutical, biotechnology, and CRO industries.
Mrs.Dilis has held a number of quality management positions at the contract clinical research, contract laboratory, and contract auditing organizations. Prior to that, she acquired her hands-on auditing and computer systems validation experience at two international CROs, a nonclinical laboratory, and a major biotechnology company.
Mrs. Dilis has proven track of professional accomplishments in developing and maintaining highly effective GLP/GCP/cGMP quality assurance/management and regulatory compliance systems, as well as, delivering on-time and on-budget auditing, training, technology acquisition and validation projects. She possesses superior knowledge of the drug development process, domestic and international regulations, directives, and guidances.
Mrs. Dilis served as the Director of Pacific Regional Chapter Society of Quality Assurance (PRCSQA), active member of Society of Quality Assurance (SQA) and is SQA Registered Quality Assurance Professional (GCP).
Mrs. Dilis earned her Juris Doctor degree at the New England School of Law, and Bachelors of Science degree from Providence College.